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The devil is in the details when it comes to research coordinators
Study sponsor outlines a dream coordinator’s job description
The audit team from Johnson & Johnson (J&J) Pharmaceutical Research and Development in San Diego has never hired a clinical research coordinator (CRC), but that doesn’t mean it doesn’t have some very strong opinions about the skills a good one should have.
James J. Rava, the associate director of global quality assurance for the J&J unit, and Cheryl Zigrand, a senior associate for global quality assurance, practically in unison state that the No. 1 attribute of a great CRC is being detail-oriented.
"They have to be very organized, almost obsessive-compulsive," Rava says. "A protocol requires a lot of making sure that all goes according to plan. The physicians, who are the principal investigators, won’t be making sure of that. The nurse has to."
Why a nurse? Rava says that while others might make good coordinators, most protocols require tasks that need a licensed professional to do — such as blood draws.
"A medical assistant can take vital signs, but a nurse can assess them," he says. "Nurses can do more sophisticated procedures and make a clear initial evaluation based on that patient’s history."
Other credentials that work well in the role include physicians’ assistants and nurse practitioners.
"If there is a phase one trial with 15 subjects, and every one of them needs a blood draw every half hour, someone has to be there to do it," adds Zigrand. "It’s great if the physician has the time to do that, but they are usually busier than that. You have to have someone else who is licensed to perform that task in that state there to do that task."
Make it a team effort
If you don’t have a description for the position — or for any position — consider letting the existing employees create it, says Helen M. Pavilonis, RN, MSN, OCN, clinical research manager at the Comprehensive Cancer Center at Duke University in Durham, NC.
"Then you can revise and tweak it by adding and deleting," she adds.
Pavilonis also has picked the brains of former clinical trial coordinators, looked at sample job descriptions from the Cancer and Leukemia Group B research cooperative, and checked her descriptions with other groups at Duke.
"We are a huge institution, and every disease has its own research going on," she explains. "And for every disease, there are variations in what they do. We have seven teams in oncology alone."
One example of how the job descriptions can differ: for cancer research, the research subjects are always sick patients; while for other diseases, phase one study subjects are likely to be healthy volunteers. That can make a huge difference to how a coordinator will enroll research subjects, she says.
Be specific about job duties
There’s probably no one who fits the ideal mold for research coordinators completely. Despite that, it’s still important to have a job description that outlines what the ideal person would do, says Elizabeth E. Hill, RN, DNSc, director of the clinical research management program and assistant professor at Duke’s School of Nursing.
"I have found that if the job description isn’t clearly spelled out, the employee can simply refuse to do something that is a critical piece of your overall requirement," she says.
"Or they may not realize it’s even something they are supposed to be doing, and no one knows they haven’t done it until you need a key piece of information that isn’t there," Hill explains.
She draws a parallel between creating a job description and doing research.
"When I’m doing research or helping other people develop a protocol, I always encourage them to do at least a simple pilot. But if they can’t do that for some reason, I tell them to really step through — one piece at a time — everything that will go on in the study and document it so they can identify problems up front and won’t miss important things that need to be done. I do the same thing, more or less, with a job description," Hill adds.
"First, I need to know clearly what knowledge base and skills I need," she continues. "So I think through that carefully, a piece at a time. As an extreme example, suppose part of the job involves driving blood samples to a distal location. Then I have to make sure they have a valid driver’s license and a car."
Pavilonis cites another reason for making sure you have an accurate job description: Evaluations usually are based on them.
"You have to make sure you have it right or how can you determine how well someone is doing?" she asks.
17 responsibilities for the dream candidate
Zigrand and Rava say they have thought a lot about what every great CRC needs to be able to do and have come up with a list of duties and responsibilities that administrators should think about inserting into their coordinator job descriptions.
1. Coordinates trials in accordance with established protocols, Food and Drug Administration (FDA) regulations, institutional policies, and ethical clinical practice. Of all of those, Zigrand thinks that the FDA piece is the weakest link at the sites she visits. "We often get questions about some of the audit observations we make and have to point out to them the FDA regulations that say they have to do something in a particular way," she says. "They aren’t always aware of the regulations under which they should be working."
2. Determines patients’ clinical protocol eligibility. The right patients have to be in a study not just to make sure that the study results are accurate, but also because of patient safety issues, says Zigrand. The wrong patient taking an experimental drug can have disastrous, even deadly, consequences.
3. Maintains research supplies inventory. "That could mean the case report forms that they transcribe the source data to, sample kits for the blood draws, and the medication itself," says Zigrand. "The coordinator has to keep very good track of all that comes in and all that goes out. Everything has to be documented."
4. Collects all protocol data.
5. Assists with the necessary staff inservices for protocols.
6. Communicates protocol needs to other departments. Many times, the patients for a study don’t come from the practice that is conducting it but are referred by ancillary groups, says Rava. The coordinator has to be a great communicator and be able to communicate to other departments or other offices what the needs are so that the right people are referred.
7. Interacts with patients directly during clinic visits and by phone. "They have to learn the protocol well enough that they can communicate it to patients in terms they can understand," Zigrand says.
It requires a certain flexibility, says Rava, being able to explain the consent form to all test subjects in their native language and in terms they can understand and then turn around and discuss the same subject with a physician on a peer-to-peer level.
8. Analyzes and evaluates clinical data. Having someone who can just tick the appropriate box on a form isn’t enough, Rava says. "We don’t need them to be biostatisticians, but they have to be alert about what patients experience during the study and determine if there are any events that are occurring across the patient base. They have to be able to trend it both on paper and in their heads."
9. Develops and maintains organized record files. "We have to have great files, not just for the patient’s own well being, but because we and the FDA will audit them," he says. "If it wasn’t documented, then when we come two years later, as far as we are concerned, it didn’t happen."
10. Collects or supervises data collection for study documents. Progress and visit notes and other source documents have to be clearly transcribed, consolidated, and configured for the study forms, Rava says.
11. Demonstrates an ability to set priorities and to achieve maximum productivity and efficiency.
12. Maintains professional licensure and competency.
13. Willingness and ability to travel to the sponsor’s investigator meetings prior to the onset of the study.
14. Demonstrates the ability to follow through completely and effectively with a minimum amount of direct supervision. Rava says that for most physicians, conducting a study is a second job. "He or she makes rounds, has clinic patients, and may be doing other studies," he says. "The coordinator won’t get to see the physician a lot, so being a self-starter and self-motivator is important."
15. Maintains strict confidentiality in compliance with the Health Insurance Portability and Accountability Act.
16. Have appropriate communication skills that further the goal of sharing information, knowledge, and responsibilities of the study with other research team members. "The CRC runs the study," says Rava. "They have to be able to communicate its strengths and weaknesses to other team members."
17. Be a mentor. "When someone new starts, the coordinator has to be able to get that person up to speed," Rava says. In addition, all team members have to be able to handle other team roles and fill when necessary.
Never assume the job description is static, though. "For us, our research nursing descriptions have largely stayed the same," Pavilonis notes. "But our coordinator position has had some minor modifications." Review it yearly, she suggests, and whenever you hire someone new, take another look at it.